A phase III study evaluating Gazyva (obinutuzumab) plus CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma did not meet its primary endpoint of progression-free survival compared to Rituxan (rituximab) plus CHOP chemotherapy, according to Genentech, a member of the Roche Group.
Results from a phase III trial of patients with metastatic colorectal cancer demonstrated that Erbitux (cetuximab) plus FOLFOX improved outcomes—including progression-free survival, overall survival and best overall response rate—when compared with FOLFOX alone.
Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.
Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.
Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency accepted a Marketing Authorization Application for Pegfilgrastim, a proposed biosimilar for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes. In... […]
The European Medicines Agency granted a PRIority MEdicines, or PRIME, designation for DNX-2401 as a treatment for recurrent glioblastoma. The PRIME designation was launched by the EMA in March to accelerate the regulatory approval of breakthrough therapies that target an unmet medical need. The objective is to provide patients who have few treatment options with... […]
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization of Onivyde (irinotecan liposome injection, nal-IRI), in combination with 5-fluorouracil and leucovorin, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy.
Applications are being accepted for the ACMG Foundation/Shire Laboratory Geneticist Fellowship Awards and Clinical Genetics Residency Program. The program will facilitate 10 one-to-two-year training awards for medical geneticists over the next three years, after a $1.65 million commitment from Shire.
Foundation Medicine approached NCI with the idea to make their data useful in the public domain.
Making data broadly available to clinicians and researchers has always been a part of the mission for Foundation Medicine Inc., said Michael Pellini, the company's CEO.
